[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613532":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":54,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Uniformed Services University of the Health Sciences","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TBI Cohort",null,"Patients with a history of Traumatic Brain Injury (TBI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 40.",[13],"Drug: Xeomin (incobotulinumtoxinA)",{"label":15,"type":10,"description":16,"interventionNames":17},"AHI Cohort","Patients with a history of Anomalous Health Incidents (AHI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 20.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Xeomin (incobotulinumtoxinA)","Patients receive their scheduled Xeomin treatment as prescribed by their physician as part of their standard of care. The treatment protocol (dosage, injection sites, etc.) will be documented.",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"David L Brody, MD, PhD","CONTACT","314-537-6453","David.brody@usuhs.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"National Intrepid Center of Excellence (NICOE)","RECRUITING","Bethesda","Maryland","20814","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-77.10026,38.98067,{"lat":43,"lon":42},[46,48,52],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":47},"david.brody@usuhs.edu",{"name":49,"role":27,"phone":50,"phoneExt":10,"email":51},"Ananya Tripathi, MS","443-876-0609","ananya.tripathi@usuhs.edu",{"name":26,"role":53,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"David Brody","Professor of Neurology, Uniformed Services University","100613532","efficacy-of-xeomin-for-migraines-in-patients-with-traumatic-brain-injuries-vs-anomalous-health-incidents-100613532",false,"NCT07267819","Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents","The Efficacy of Xeomin as a Prophylactic Therapy for Migraine in Patients With Traumatic Brain Injuries (TBIs) Versus Anomalous Health Incidents (AHIs)","Inclusion Criteria:\n\n* At least 18 years of age\n* Able to provide written consent in English\n* An employee of the US Government, or an adult family member of a US Government employee\n* Have received Xeomin treatment to prevent migraine related to TBI or AHI at a Military Treatment Facility or other US Medical Facility\n* Able to participate in at least 80% of the assessments\n* A US Citizen and not a dual national of the country where you are currently located\n\nExclusion Criteria:\n\n* Prisoner\n* Decisionally impaired and unable to provide informed consent\n* Non-US citizen","ALL","18 Years",{"count":67,"type":68},60,"ESTIMATED","OBSERVATIONAL","This cohort study aims to compare the efficacy of Xeomin injections for migraine management in patients with a history of Traumatic Brain Injury (TBI) versus those with a history of Anomalous Health Incidents (AHI). The study will be conducted at the National Intrepid Center of Excellence (NICOE) in Bethesda, MD. The primary objective is to determine if Xeomin injections result in different outcomes for migraine management between TBI and AHI patients. This is a combined retrospective and prospective cohort study design. Patients scheduled for Xeomin treatments will be categorized into TBI and AHI groups. For the prospective cohort, participants will complete a baseline questionnaire, receive their scheduled Xeomin treatment, and participate in follow-up interviews at 4-6 weeks and 10-12 weeks post-treatment. For the retrospective cohort, similar information will be acquired from existing records. Statistical analysis will compare migraine characteristics and treatment responses between the two groups. All data will be de-identified to protect patient privacy.",[72,73,74],"Migraine","Traumatic Brain Injury","Anomalous Health Incidents",[76,77,78,72,79],"Anomalous health incident","Traumatic brain injury","Headache","Botulinumtoxin","2025-11-24",{"date":82,"type":83},"2025-12-05","ACTUAL",{"date":85,"type":83},"2025-08-05",{"date":87,"type":68},"2028-06-06",{"name":5,"class":6},1]